Adam K, Oswald I
Br J Clin Pharmacol. 1982 Jul;14(1):57-65. doi: 10.1111/j.1365-2125.1982.tb04934.x.
1 Twelve volunteers, of mean age 60 years, took part in a double-blind, balanced cross-over study, to compare effects of chlormezanone 400 mg and nitrazepam 5 mg on electrophysiologically-recorded and subjectively-rated sleep. 2 In the first week of administration nitrazepam caused a significant shortening of the time to fall asleep, but following withdrawal subjects took longer to fall asleep than during the baseline period. 3 Both chlormezanone and nitrazepam initially caused increase of sleep duration and less interruption of sleep by wakefulness. By the third week, for chlormezanone this effect was no longer significant, and for nitrazepam there was a significant decline in the effect. There was no statistically significant difference between the two drugs for these measures. 4 The drugs differed little in their effects on the amount of the various sleep stages, except that nitrazepam significantly reduced the duration of slow wave sleep, whereas chlormezanone had no significant effect on slow wave sleep. Both drugs reduced the amount of REM sleep in the first 6 h of sleep but only nitrazepam reduced the percentage of the time spent in REM sleep of the whole night. 5 Subjects' own ratings of sleep quality showed that both of the drugs improved sleep, but following withdrawal it was only after nitrazepam that there was impairment of the quality of sleep. Neither drug affected subjective alertness in the morning.
12名平均年龄为60岁的志愿者参与了一项双盲、均衡交叉研究,以比较氯美扎酮400毫克和硝西泮5毫克对通过电生理记录的睡眠以及主观评定的睡眠的影响。
在给药的第一周,硝西泮显著缩短了入睡时间,但停药后受试者入睡时间比基线期更长。
氯美扎酮和硝西泮最初都使睡眠时间增加,且因觉醒导致的睡眠中断减少。到第三周,氯美扎酮的这种效果不再显著,硝西泮的效果则显著下降。在这些指标上,两种药物之间没有统计学上的显著差异。
两种药物对各个睡眠阶段时长的影响差异不大,只是硝西泮显著缩短了慢波睡眠时长,而氯美扎酮对慢波睡眠没有显著影响。两种药物都减少了睡眠前6小时的快速眼动睡眠量,但只有硝西泮降低了整夜快速眼动睡眠所占的时间百分比。
受试者对睡眠质量的自我评定表明,两种药物都改善了睡眠,但停药后,只有在服用硝西泮后睡眠质量才出现下降。两种药物都未影响早晨的主观警觉性。